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SPEAKER: John E. Lincoln

OVERVIEW:
This webinar will discuss the 9 required elements of a Design Control System. It will consider different methods of implementation, and expectations of the U.S. FDA, proven by documentation.

Such an analysis takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry) need to do to "toughen" the safety and efficacy of medical devices. A review of recent information from the Agency, including recent Working Group findings and Reports, as well as other goals of the Agency that have already been translated into action in the field in the past two years, provide further direction in areas of concern and what to expect in the future. Anticipation and addressing such on-going increased Agency emphasis in product design and modifications - change control proactively will further prove a company is "in control" re: the CGMPs, and assist documenting entire medical product development process.

Why should you attend: The FDA expects companies to perform meaningful, results driven Design Control activities as defined in the CFR, for both new and changed devices. The company is held fully responsible for deciding when to start and the specific documentation to meet the 9 requirements. Beyond compliance, these 9 elements can be a powerful tool in reducing "time to market" - "fast cycle" product development.

In addition, growing high-profile field problems indicate that design control and it's effect on regulatory review activities are not yet fully utilizing the power of current risk management tools, which must be a part of the design control process - the ISO 14971 "model". A growing push by the Agency to strengthen the 510(k) process, and review existing devices with above normal adverse events are additional concerns, to be factored into the design control process. The resulting documentation can have other far-reaching uses in a company. Proper design control requires a defined "start" date, and the systematic - SOP-defined implementation of formal methods with documented, and defensible, rationale. When properly executed, it is a powerful product development project management tool.

Areas Covered in the Session:
- FDA Device Clearance - Changes in Direction
- Current Design Control Requirements
- Defining the "Start" Date and Its Significance
- The 9 Design Control Elements and Their Implementation and Documentation
- Their Implementation and Documentation
- "Retroactive" Design Control
- The Business Case for Design Control

SPEAKER PROFILE:
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.

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